Cleared Traditional

K262960 - Cerclage Cabling System

K262960 is an FDA 510(k) clearance for Cerclage Cabling System, manufactured by Pioneer Surgical Technology, Inc. dba EXALTA Group. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K262960 · Pioneer Surgical Technology, Inc. dba EXALTA Group · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
65d
Days
Class 2
Risk

K262960 is an FDA 510(k) clearance for the Cerclage Cabling System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. dba EXALTA Group (Marquette, US). The FDA issued a Cleared decision on October 29, 2026 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262960

510(k) Number K262960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2026
Decision Date October 29, 2026
Days to Decision 65 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDQ Cerclage, Fixation

All 130
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K262960.
Cable-Ready® Cable Grip System
K261271 · Pioneer Surgical Technology, Inc. · Jul 2026
Stitch Cerclage – Suture Tapes
K243905 · GM Dos Reis Industria e Comercio Ltda. · Aug 2025
Arthrex FiberTape and TigerTape Cerclage Sutures
K243344 · Arthrex, Inc. · Feb 2025
Mbrace Cable
K232733 · Medacta International S.A. · May 2024
ACCORD Cable System
K233949 · Smith & Nephew, Inc. · Mar 2024
VariTrax Sternal CircumFixation System
K232986 · Circumfix Solutions, Inc. · Jan 2024
K262960 · Cerclage Cabling System
Download PDF FDA Summary Pioneer Surgical Tech…